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Session Description: This session is a sampling of some important statistical challenges that are present in the design and analysis of some diagnostic products. Speakers/Titles: "Classification rules for high-dimensional markers: searching for complementary marker pairs", Stuart Baker, NIH/NCI "Comparing the Diagnostic Accuracies of Two Tests in Studies with Verification Bias", Marina Kondratovich, FDA/CDRH "Computer Simulation in Medical Diagnostic Assay Calibration Evaluation", Ping Shi, PhD, Abbott Diagnostics

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Comparing Diagnostic Accuracies of Two Tests in the Studies with Verification Bias Marina Kondratovich, Ph.D. Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration. No official support or endorsement by the Food and Drug Administration of this presentation is intended or should be inferred. September, 2005